CMS Issues Vaccine Mandate Rule for Healthcare Workers

November 11th, 2021

By Gary Evans, Medical Writer

While emphasizing the national threat of the pandemic and the safety and efficacy of the SARS-CoV-2 vaccines, the Centers for Medicare & Medicaid Services (CMS) came down to one bedrock reason healthcare workers now face mandated immunization: their ethical duty to protect patients.

“Patient safety is a central tenet of the ethical codes and practice standards published by health care professional associations, licensure and certification bodies, and specialized industry groups,” the CMS said in an Interim Final Rule published on Nov. 5, 2021. “Health care workers also have a special ethical and professional responsibility to protect and prioritize the health and well-being of those they are caring for, as well as not exposing them to threats that can be avoided. This holds true not only for health care professionals, but also for all who provide health care services or choose to work in those settings. The ethical duty of receiving vaccinations is not new, as staff have long been required by employers to be vaccinated against certain diseases.”

The CMS asserted its authority to establishes health and safety standards under its “Conditions of Participation,” and said those who fail to comply with the vaccination rule face the full gamut of penalties. These include fines, denial of payment for new admissions, or “termination of the Medicare/Medicaid provider agreement.”

In addition to hospitals, long-term care facilities, and skilled nursing facilities, the vaccination mandate applies to ambulatory surgical centers, hospices, psychiatric residential treatment, homecare, and other healthcare settings. (See the CMS interim rule for the full list). Overall, the vaccine requirement applies to some 17 million healthcare workers and approximately 76,000 medical facilities.

The CMS has set two deadlines for vaccination, the first effective one month after publication of the rule and the second a month later. Under these requirements all staff must have received at least the first dose of a primary series (Pfizer, Moderna) or a single-dose COVID-19 vaccine (Janssen) by Dec. 6, 2021, unless they have been granted an exemption for medical or religious reasons.

By Jan. 4, 2022, all non-exempt staff must have received the second shot in an immunization series. “We believe it is necessary to begin staff vaccinations as quickly as reasonably possible,” the agency stated. In keeping with the Centers for Disease Control and Prevention, the CMS is not requiring the booster shot or including it in its definition of those fully vaccinated.

“Although an individual is not considered fully vaccinated until 14 days after the final dose, staff who have received the final dose of a primary vaccination series by the Phase 2 effective date are considered to have meet the individual vaccination [requirement],” the CMS said.

In addition to medical contraindications, the COVID-19 vaccine requirements are subject to existing federal antidiscrimination laws.

“Certain allergies, recognized medical conditions, or religious beliefs, observances, or practices may provide grounds for exemption,” the CMS noted. For those exempted under such grounds, CMS requires healthcare facilities to “have a process for ensuring the implementation of additional precautions, intended to mitigate the transmission and spread of COVID-19.”

As required by the CMS rule, hospitals and other healthcare facilities must track and document the vaccination status of all employees, including keeping records of those granted exemptions. “This documentation will be an ongoing process as new staff are onboarded,” the CMS stated.

The CMS plans to issue interpretive guidelines for the vaccine rule, which will include survey procedures. The facilities' policies and procedures will be examined to ensure all components of the rule are in place.

“We will advise and train state surveyors on how to assess compliance with the new requirements among providers and suppliers,” the CMS rule stated. “For example, the guidelines will instruct surveyors on how to determine if a provider or supplier is compliant with the requirements by reviewing the entity's records. [They] will also instruct surveyors to conduct interviews [of] staff to verify their vaccination status.”

Gary Evans, BA, MA, has written numerous articles on infectious disease threats to both patients and healthcare workers. These include stories on HIV, SARS, SARS-CoV-2, pandemic influenza, MERS, and Ebola. He has been honored for excellence in analytical reporting five times by the National Press Club in Washington, DC.